LUSTRAL TABLETS 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SERTRALINE AS HYDROCHLORIDE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

N06AB06

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

SERTRALINE AS HYDROCHLORIDE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

المجال العلاجي:

SERTRALINE

الخصائص العلاجية:

For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in prevention relapse of the initial episode of depression or recurrence of further depressive episodes.

تاريخ الترخيص:

2020-11-30

نشرة المعلومات

Lustral tablets 50 mg and 100 mg, PIL, Israel, CC 080823
1
PATIENT LEAFLET
IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
LUSTRAL
® TABLETS 50 MG
LUSTRAL
® TABLETS 100 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
SERTRALINE (AS HYDROCHLORIDE) 50 MG OR 100 MG
Inactive ingredients and allergens: See section 2 under 'Important
information about some of this
medicine's ingredients' and section 6 'Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
This medicine is not intended for use in children and adolescents
under 18 years of age.
WHAT SHOULD I KNOW ABOUT THE MEDICINE?
Antidepressants and anti-anxiety medicines increase the risk of
suicidal behavior and thoughts in
children, adolescents and young adults up to the age of 25.
When starting treatment with the medicine, patients of all ages and
their relatives should monitor
behavioral changes such as: worsening of depression, suicidal
thoughts, aggression and the like.
If changes such as these occur, refer to the doctor immediately (see
section 2).
1. WHAT IS THIS MEDICINE INTENDED FOR?
A medicine intended for the treatment of symptoms of depression in
patients with or without a history
of mania. After achieving a satisfactory response, continued treatment
with the medicine is effective in
preventing relapse of the initial depressive episode or recurrence of
further depressive episodes.
THERAPEUTIC GROUP:
This medicine belongs to the SSRI group, selective serotonin reuptake
inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or any of the
additional ingredients
contained in t

خصائص المنتج

Lustral tablets 50 mg and 100 mg, LPD, Israel, CC 080823
Page 1 of 20
LUSTRAL
® TABLETS 50MG
LUSTRAL
® TABLETS 100MG
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents,
and young adults in short-term studies. These studies did not show an
increase in the risk of
suicidal thoughts and behavior with antidepressant use in patients
over age 25; there was a
reduction in risk with antidepressant use in patients aged 65 and
older [see Warnings and
Precautions (4.4)].
In patients of all ages who are started on antidepressant therapy
monitor closely for clinical
worsening and emergence of suicidal thoughts and behaviors. Advise
families and caregivers
of the need for close observation and communication with the
prescriber [see Warnings and
Precautions (4.4)].
1. NAME OF THE MEDICINAL PRODUCT
Lustral
®
tablets 50 mg
Lustral
®
tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sertraline hydrochloride equivalent
to 50 mg or 100mg
sertraline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Sertraline 50 mg film-coated tablets are white, capsular shaped,
film-coated scored tablets
marked
‘ZLT
50’
on one side and ‘PFIZER’ on the other.
The tablet can be divided into equal
doses.
Sertraline 100 mg film-coated tablets are white, capsular shaped,
film-coated tablets marked
'ZLT 100' on one side and 'PFIZER' on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of symptoms of depression in
patients with or without a
history of mania. Following satisfactory response, continuation with
sertraline therapy is
Lustral tablets 50 mg and 100 mg, LPD, Israel, CC 080823
Page 2 of 20
effective in prevention relapse of the initial episode of depression
or recurrence of further
depressive episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Initial treatment _
_ _
Sertraline treatment should be star